EP1504829A1 - Verfahren zur Herstellung einer medizinischen Nadel - Google Patents

Verfahren zur Herstellung einer medizinischen Nadel Download PDF

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Publication number
EP1504829A1
EP1504829A1 EP03017883A EP03017883A EP1504829A1 EP 1504829 A1 EP1504829 A1 EP 1504829A1 EP 03017883 A EP03017883 A EP 03017883A EP 03017883 A EP03017883 A EP 03017883A EP 1504829 A1 EP1504829 A1 EP 1504829A1
Authority
EP
European Patent Office
Prior art keywords
needle
laser beam
portions
plane
dimensions
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP03017883A
Other languages
English (en)
French (fr)
Other versions
EP1504829B1 (de
Inventor
Adrian Fiechter
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lasag AG
Original Assignee
Lasag AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lasag AG filed Critical Lasag AG
Priority to EP03017883A priority Critical patent/EP1504829B1/de
Priority to DE60305912T priority patent/DE60305912T2/de
Priority to AT03017883T priority patent/ATE328686T1/de
Priority to TW093123105A priority patent/TWI311084B/zh
Priority to CNB2004100766089A priority patent/CN100364690C/zh
Priority to US10/911,508 priority patent/US7557325B2/en
Priority to JP2004229069A priority patent/JP2005052654A/ja
Publication of EP1504829A1 publication Critical patent/EP1504829A1/de
Priority to HK05106894.9A priority patent/HK1074597B/xx
Application granted granted Critical
Publication of EP1504829B1 publication Critical patent/EP1504829B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21G—MAKING NEEDLES, PINS OR NAILS OF METAL
    • B21G1/00—Making needles used for performing operations
    • B21G1/08—Making needles used for performing operations of hollow needles or needles with hollow end, e.g. hypodermic needles, larding-needles

Definitions

  • the present invention relates to a method of manufacturing a needle metallic medical device of the type generally used to make sutures.
  • the tubular portion arranged at the non-pointed end of the needle is intended to ensure the subsequent fixation of the suture to the needle.
  • current medical needles are typically made from of a single metal portion with one end pointed while the second end is substantially planar.
  • a blind hole is then formed in the second end to subsequently secure the fixation of a suture.
  • the blind hole is made by a laser or drill drilling process according to the desired dimensions.
  • Another disadvantage of this type of process is related to the fact that if the hole blind is poorly positioned or sized, it may be that its walls are too thin to withstand the mechanical stresses subsequently suffered during the production a suture.
  • An object of the present invention is to overcome the disadvantages of art mentioned above by providing a method of manufacturing medical needles fast, inexpensive and good-yielding, that is, good reproducibility of the quality of the needles obtained.
  • the present invention relates to a method of manufacture of the type indicated above, characterized in that during step d) a movement of relative rotation is induced between the two needle portions, on the one hand, and the beam incident laser, on the other hand.
  • the method according to the present invention is characterized by the fact that the speed of the relative rotational movement and the duration of the pulses of the laser are adjusted relative to each other in such a way that less than a relative rotation is effected during the duration of a pulse of laser beam.
  • the weld obtained is continuous and of uniform quality over the entire periphery of the needle. Since the tube welded to the main portion of the needle is manufactured by a conventional method and proven, its dimensions are guaranteed relatively accurately. Thus, dimensions of the blind hole of the needle obtained by the method according to the present invention are not subject to fluctuations, from one needle to another, as this is the case for the needles of the prior art.
  • the first portion of the present needle a substantially cylindrical shape in the region of its second end, preferably of the same dimensions as the second needle portion. Of this way, the passage from one portion to the other does not present a discontinuity when the needle is assembled.
  • the two needle portions are applied against each other. the other with a certain pressure force prior to the welding operation.
  • the method according to the invention provides a preliminary step to the welding operation during which at least two, preferably three, very small weld points are made between first and second portions of the needle for the purpose of maintaining them in a relative position suitable for the welding operation.
  • a chamfer at the end of the tube for receiving the suture, which chamfer is oriented towards the inside of the hole blind.
  • the chamfer is made by removal of material by laser heating and so as to have an arcuate cross-section circle.
  • the presence of such a chamfer facilitates the subsequent introduction of the suture thread inside the blind hole of the needle.
  • the chamfer can be advantageously achieved after the welding operation of the two needle portions, to using the same laser machining head and the same relative rotational movement between the needle formed and the incident laser beam.
  • the chamfer is typically realized by the use of two laser beams of incidence angles respective opposites and each of which allows to achieve half of the chamfer.
  • a preferred embodiment of the present invention provides to arrange the two needle portions immobile on a fixed holder while the laser beam is rotated about the axis X2 of the tubular portion. A quick movement of the two portions that must remain fixed relative to each other is indeed difficult to implement without harming the welding precision.
  • FIG. 1 represents a medical needle 100 of the type currently used and described above, in partial section.
  • This needle is typically made of a single piece between a first pointed end 101 and a second end 102 whose section is substantially flat.
  • the needle 100 is not shown only partially, its median part not being visible, the first end 101 being represented in perspective while the region of the second end is shown in section.
  • the middle part can present a rectilinear or curvilinear form.
  • a blind hole 103 is made in the region the second end 102 for the purpose of securing a suture (not shown) in a subsequent manufacturing step.
  • the blind hole 103 is made by a laser drilling method.
  • this laser drilling method has a significant disadvantage which concerns the accuracy of the positioning of the hole 103 with respect to the needle and that the accuracy of the sizing of the hole obtained.
  • a bad sizing of the hole 103 can lead to poor hold of the suture (no shown) which is intended to be threaded, as well as an irregular shape of the hole 103.
  • FIG. 2 shows a medical needle 1 obtained by a method according to the present invention in a view similar to the view of FIG.
  • the needle 1 comprises two portions, a first main portion 2, partially represented, and a second portion 3 of tubular form.
  • the first main portion 2 comprises a first pointed end 4 and a second end 5 contained in a plane P1.
  • the middle part of the first main portion 2, which is not shown, may have any shape, that is to say, it can be rectilinear or curvilinear without its shape impact on the manufacturing process according to the present invention.
  • the second portion 3 preferably has an axial symmetry of axis X2 and comprises a first end 6 intended to be welded to the first portion 2, contained in a plane P2, substantially perpendicular to the axis X2.
  • the second portion 3 further comprises a second end 7 through which it is provided to insert a suture in a subsequent manufacturing step to bind the suture to the needle 1.
  • the suture must finally be housed inside the blind hole 8 formed by the meeting of the first 2 and second 3 portions of the needle 1.
  • chamfer 10 preferably has a substantially arcuate section of circle, with a radius of curvature of the order of a few tens or hundreds of micrometers, preferably between 10 and 200 micrometers, and ensures function of guiding the suture when it is threaded into the needle. This This measure makes it possible to significantly soften the conditions for insertion of the suture and to translated by a significant time saving in the wire assembly operation and of the needle which, typically, is automated with a rate of operation high of the order of several assemblies per second.
  • FIG. 2 shows in addition a structural detail of the needle 1, directly related to its manufacturing process. Indeed, we see the presence of a solder 11 at the interface between the first 2 and second 3 portions of the needle.
  • the weld extends over the entire thickness of the wall of the second tubular portion, as shown in FIG. 2, so as to guarantee a optimal rigidity of the connection between the two portions of the needle.
  • the process of manufacture according to the present invention makes it possible to form a continuous weld 11 on the entire periphery of the second portion 3 and excellent quality both on the plan mechanical only visually.
  • the first 2 and second 3 portions of the needle have been represented here with identical dimensions in the regions of their respective ends intended to be welded together.
  • the needle 1 has an envelope without irregularity from its surface from its pointed end 4 to its end 7 serving to fix the suture.
  • this characteristic which corresponds to a variant preferred is not limiting.
  • the skilled person can adapt the dimensions first and second needle portions according to their own needs without particular difficulty and without departing from the scope of the present invention.
  • the transverse dimensions of the second needle portion be less than or equal to that of the first portion.
  • FIGS. 3 and 4 show two examples of implementation of the method according to the present invention, with different welding devices.
  • FIG. 3 is a schematic representation of a first embodiment of performing the method according to the invention, according to which the first 2 and second 3 portions of the needle 1 are rotated against a laser beam still incident.
  • a work table 30 whose inclination of the working surface 31 is preferably capable of being adjusted according to at least an axis of rotation, as indicated by the arrow F1, to be able to adjust the angle incidence of the laser beam on the solder region if necessary.
  • a motor 32 is secured to the work surface 31 and drives a shaft 33 in rotation.
  • the shaft 33 carries a workpiece tool 34, which is rigidly attached to it, for supporting a needle 1 during the welding operation.
  • the workpiece tool 34 is provided with conventional means to ensure the maintaining the needle 1.
  • the device for implementing the method according to the method of embodiment of FIG. 3 comprises a laser source 35 emitting a laser beam 36 optical characteristics adapted to the operating conditions envisaged, especially in terms of power and frequency of pulses.
  • the device of FIG. 3 comprises optical means conventional means for modulating the shape of the laser beam 36, such as lenses 37, 38 and 39, as well as optical means for changing the direction of the laser beam 36, if necessary, such as a mirror 40.
  • optical means conventional means for modulating the shape of the laser beam 36, such as lenses 37, 38 and 39, as well as optical means for changing the direction of the laser beam 36, if necessary, such as a mirror 40.
  • the workpiece tool 34 is rotated on itself, in the direction indicated by the arrow F2, of such way that the needle turns on itself, the interface between its two remaining portions located opposite the incident laser beam 41.
  • An important parameter of the process according to the present invention then consists to adjust the values of the duration of the pulses of the laser beam 36 and the speed the rotation of the workpiece tool 34 relative to each other, so that During the duration of a complete pulse of the laser beam, the workpiece tool 34 performs at least one complete whole on itself.
  • the welding of the first and second needle portions in two steps.
  • a sleeve 42 of the type represented on the Figure 3 for illustrative and non-limiting.
  • the sleeve 42 has a shape generally cylindrical and comprises a bearing surface 43 against which is arranged the second portion 3 of the needle 1.
  • the sleeve 42 is then threaded on the end 5 of the first portion 2 of needle carried by the workpiece tool 34, of such way that the first and second needle portions are disposed in abutment one against the other.
  • the sleeve also has a plurality of openings 44 regularly distributed around its periphery and located opposite the interface region between the first and second needle portions.
  • the sleeve 42 shown comprises 3 openings 43 arranged at 120 ° from each other.
  • the incident beam 41 radiates the regions of the interface between the first and second needle portions located opposite the openings 43 to form small weld spots.
  • the sleeve 42 is removed and the workpiece tool 34 is again driven in rotation to perform the continuous welding, as mentioned above.
  • the method of manufacturing medical needles according to the present embodiment of the invention is applicable to needles whose section is not circular.
  • the application of this process to needles of different shapes leads to much lower results in term of production speed, in so far as the use of robotic arm type are required. Indeed, the movements made by a robotic arm in this case are more complex, so the welding process is overall slower.
  • FIG. 4 represents a preferred embodiment of the method according to FIG. present invention schematically.
  • the first 2 'and second 3' portions of the needle 1 ' are held in a fixed position during the operation of welding while the incident laser beam is driven in a movement of rotation.
  • the present mode of implementation is therefore more favorable from the point of view of of the stability of the relative position of the two parts to be welded together, same as from the point of view of their positioning with regard to the laser beam incident.
  • a laser source 50 emitting a laser beam 51 through a mechanical system 52 comprising conventional optical means for adjusting the characteristics of the laser beam incident 53.
  • the system 52 further comprises a reflective surface 54 as well as mechanical means (not shown) for rotating the surface reflecting 54 in the direction indicated by the arrow F3 in Figure 4.
  • the laser beam is then diverted towards a second surface reflector 55 of annular overall shape and having a concave shape in cross-section, as shown in FIG. 4.
  • the incident laser beam 53 is then emitted from the second reflecting surface 55, towards the needle 1, with a certain angle of incidence adjustable through the mechanical means of the system 52.
  • the needle 1 is arranged in a workpiece holder 56, the positioning of the system 52 and the needle being adjusted so that the laser beam incident presents its focal point substantially in the region of the interface between the first 2 and second 3 portions of the needle 1.
  • the laser beam is emitted and driven in a rotational movement through the rotation of the surface reflector 54, so that the incident laser beam travels the periphery of the needle at the interface between the two portions of the latter.
  • the values the speed of the rotation of the reflecting surface 54 and the duration of the pulses of the laser beam 51 are adjusted relative to each other, such in the course of the duration of a complete pulse of the laser beam, the reflective surface 54 performs at least one complete whole on itself.
  • the method according to the present invention has an additional step of polishing the needle casing 1 obtained after completion of the welding.
  • the skilled person can plan to use a direct optical coupling between the laser source and the optical devices for modifying the laser beam or optical fiber coupling according to its needs, without departing from the the present invention.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Surgical Instruments (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Laser Beam Processing (AREA)
EP03017883A 2003-08-05 2003-08-05 Verfahren zur Herstellung einer medizinischen Nadel Expired - Lifetime EP1504829B1 (de)

Priority Applications (8)

Application Number Priority Date Filing Date Title
EP03017883A EP1504829B1 (de) 2003-08-05 2003-08-05 Verfahren zur Herstellung einer medizinischen Nadel
DE60305912T DE60305912T2 (de) 2003-08-05 2003-08-05 Verfahren zur Herstellung einer medizinischen Nadel
AT03017883T ATE328686T1 (de) 2003-08-05 2003-08-05 Verfahren zur herstellung einer medizinischen nadel
TW093123105A TWI311084B (en) 2003-08-05 2004-08-02 Method for manufacturing a medical needle
CNB2004100766089A CN100364690C (zh) 2003-08-05 2004-08-04 医用针的加工方法
US10/911,508 US7557325B2 (en) 2003-08-05 2004-08-05 Method for manufacturing a medical needle
JP2004229069A JP2005052654A (ja) 2003-08-05 2004-08-05 医療用針の製造方法
HK05106894.9A HK1074597B (en) 2003-08-05 2005-08-10 Method for manufacturing a medical needle

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP03017883A EP1504829B1 (de) 2003-08-05 2003-08-05 Verfahren zur Herstellung einer medizinischen Nadel

Publications (2)

Publication Number Publication Date
EP1504829A1 true EP1504829A1 (de) 2005-02-09
EP1504829B1 EP1504829B1 (de) 2006-06-07

Family

ID=33547639

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03017883A Expired - Lifetime EP1504829B1 (de) 2003-08-05 2003-08-05 Verfahren zur Herstellung einer medizinischen Nadel

Country Status (7)

Country Link
US (1) US7557325B2 (de)
EP (1) EP1504829B1 (de)
JP (1) JP2005052654A (de)
CN (1) CN100364690C (de)
AT (1) ATE328686T1 (de)
DE (1) DE60305912T2 (de)
TW (1) TWI311084B (de)

Families Citing this family (8)

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US8250729B2 (en) * 2006-07-12 2012-08-28 University Of Utah Research Foundation 3D fabrication of needle tip geometry and knife blade
US8062437B2 (en) * 2007-06-01 2011-11-22 Ethicon, Inc. Thermal forming of refractory alloy surgical needles and fixture and apparatus
CN101559465B (zh) * 2009-05-15 2010-11-17 淮阴工学院 手术针弯曲装置
DE102009021788A1 (de) * 2009-05-18 2010-11-25 Minebea Co., Ltd. Laserschweißverfahren
DE102010041720A1 (de) * 2010-09-30 2012-04-05 Robert Bosch Gmbh Schweißverfahren, Schweißvorrichtung und Verbundteil
JP5017483B1 (ja) 2011-08-05 2012-09-05 株式会社医研工業 アイレス縫合針の製造方法
CN104874911B (zh) * 2015-05-27 2016-10-12 四川大学 一种微探针尖端成形激光加工系统
US10794523B2 (en) * 2015-12-14 2020-10-06 Wilmarc Holdings, Llc Laser induced sealing of concentrically layered materials

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US3835912A (en) * 1973-06-25 1974-09-17 S K S Ltd Method of joining a filament to a metal rod
FR2520224A1 (fr) * 1982-01-27 1983-07-29 Cetehor Aiguille de suture medicochirurgicale
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US5012066A (en) * 1989-08-31 1991-04-30 Matsutani Seisakusho Co., Ltd. Method of and apparatus for manufacturing eyeless suture needle

Also Published As

Publication number Publication date
DE60305912T2 (de) 2007-02-01
TWI311084B (en) 2009-06-21
CN1579666A (zh) 2005-02-16
DE60305912D1 (de) 2006-07-20
CN100364690C (zh) 2008-01-30
JP2005052654A (ja) 2005-03-03
HK1074597A1 (zh) 2005-11-18
US20050049639A1 (en) 2005-03-03
ATE328686T1 (de) 2006-06-15
TW200518857A (en) 2005-06-16
EP1504829B1 (de) 2006-06-07
US7557325B2 (en) 2009-07-07

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